AAMI TIR80001 2 1 2012
$140.32
AAMI/IEC TIR80001-2-1:2012 – Application of risk management for IT-networks incorporating medical device-Part 2-1: Step by step risk management of medical IT-networks; Practical applications and examples
| Published By | Publication Date | Number of Pages |
| AAMI | 2012 | 76 |
Step-by-step guide to help in the application of risk management when creating or changing a medical IT-network.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 1 | ANSI/AAMI/IEC TIR80001-2-1:2012, Application of risk management for IT-networks incorporating medical devices — Part 2-1: Step by step risk management of medical IT-networks; Practical applications and examples |
| 3 | Title page |
| 4 | Copyright information |
| 5 | AAMI Technical Information Report ANSI Technical Report |
| 6 | Contents |
| 9 | Glossary of equivalent standards |
| 12 | Committee representation |
| 13 | Background of ANSI/AAMI adoption of IEC/TR 80001-2-1:2012 |
| 14 | FOREWORD |
| 16 | INTRODUCTION |
| 17 | 1 Scope 2 Normative references 3 Terms and definitions |
| 23 | 4 Prerequisites 5 Study of terms used in risk management 5.1 Overview |
| 24 | 5.2 Hazards 5.3 Hazardous situations |
| 25 | 5.4 Foreseeable sequences of events and causes 5.5 Unintended consequence |
| 26 | 5.6 Risk control measures (mitigations) |
| 27 | 5.7 Degrees of risk 5.8 Checking wording |
| 28 | 6 The steps 6.1 Overview of the steps 6.2 A basic example using the 10 steps 6.2.1 General 6.2.2 Initial risk – Steps 1 – 5 (Figure 2) |
| 29 | 6.2.3 Risk control and final risk – Steps 6 – 10 (Figure 3) |
| 32 | 7 IEC 80001-1:2010, Subclause 4.4: Step by step 7.1 General 7.2 Application of Subclause 4.4.1: Document all risk management elements 7.3 Note about risk evaluation 7.4 The 10-step process 7.4.1 STEP 1: Identify hazards and hazardous situations |
| 33 | 7.4.2 STEP 2: Identify causes and resulting hazardous situations 7.4.2.1 General 7.4.2.2 Multiple causes per hazardous situation |
| 34 | 7.4.2.3 Multiple hazardous situations per cause 7.4.3 STEP 3: Determine unintended consequences and estimate the potential severities 7.4.4 STEP 4: Estimate the probability of unintended consequence 7.4.4.1 General 7.4.4.2 Probability estimations |
| 35 | 7.4.5 STEP 5: Evaluate risk |
| 36 | 7.4.6 STEP 6: Identify and document proposed risk control measures and re-evaluate risk (return to Step 3) 7.4.6.1 General 7.4.6.2 Identify risk control measures |
| 37 | 7.4.6.3 Select risk control measure 7.4.6.4 Re-evaluate risk 7.4.6.5 Risk/benefit analysis 7.4.7 STEP 7: Implement risk control measures 7.4.8 STEP 8: Verify risk control measures 7.4.8.1 General |
| 38 | 7.4.8.2 Verification of effectiveness 7.4.8.3 Verification of implementation 7.4.9 STEP 9: Evaluate any new risks arising from risk control |
| 39 | 7.4.10 STEP 10: Evaluate and report overall residual risk 7.5 The steps and their relationship to IEC 80001-1 and ISO 14971 |
| 41 | 8 Practical examples 8.1 General 8.2 Example 1: Wireless patient monitoring during patient transport 8.2.1 Full description of context 8.2.2 Description of network under analysis 8.2.3 The 10 Steps |
| 44 | 8.3 Example 2: Remote ICU / Distance medicine 8.3.1 Full description of context 8.3.2 Description of network under analysis 8.3.3 The 10 Steps |
| 47 | 8.4 Example 3: Post Anesthesia Care Unit (PACU) 8.4.1 Full description of context 8.4.2 Description of network under analysis |
| 48 | 8.4.3 The 10 Steps |
| 53 | 8.5 Example 4: Ultrasound – Operating System (OS) vulnerability 8.5.1 Full description of context 8.5.2 Description of network under analysis 8.5.3 The 10 Steps |
| 57 | Annex A (informative) Common hazards, hazardous situations, and causes to consider in medical IT-networks A.1 Typical hazards in medical it-networks A.2 Types of hazardous situations |
| 58 | A.3 Common causes in medical IT-networks A.4 Relationship between required network characteristics and hazards |
| 59 | A.5 Relationship between hazards, foreseeable sequences, and causes |
| 61 | A.6 Hazards, causes, foreseeable sequences, and hazardous situations |
| 62 | Annex B (informative) List of questions to consider when identifying hazards of the medical IT-network |
| 63 | Annex C (informative) Layers of medical IT-networks where errors can be found C.1 Overview C.2 Errors and faults |
| 66 | Annex D (informative) Probability, severity, and risk acceptability scales used in the examples in this technical report |
| 69 | Annex E (informative) Monitoring risk mitigation effectiveness E.1 Overview E.2 Verify the effectiveness of risk control measures E.3 Verify the effectiveness of inherent key property control by design |
| 70 | E.4 Verify the effectiveness of protective measures E.5 Verify the effectiveness of information for key properties to mitigate risk E.6 Verification of the design and execution of the risk management process |
| 72 | Annex F (informative) Risk analyzing small changes in a medical IT-network |
| 73 | Annex G (informative) Example of Change Window Form |
| 74 | Annex H (informative) Template for examples |
| 76 | Bibliography |
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